Design History Files and Technical Files / Design Dossiers Required Under the U.S. FDA CGMPS and the EU’s MDD

This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.

Why Should You Attend:

Global companies must meet different product design documentation for the U.S. and the European Union / Common Market.  The cGMPs mandate Design Control and the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical File or Design Dossier.  Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF may soon borrow some features required in the TF/DD.  Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both.  What are DMRs and DHRs relationship to DHFs, TF/DDs?

Areas Covered in the Seminar:

• The U.S. FDA's DHF.
• The EU's MDD and the Technical File / Design Dossier.
• Design Control 'Over Time' vs. a Product 'Snapshot in Time'.
• DHF "Typical" Contents.
• TF / DD Expected Contents.
• Parallel Approaches to Documentation -- Teams.

Who Will Benefit:

All personnel involved in the U.S. FDA-regulated and CE-marking environments.  Especially those involved in new medical device / combination product development, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF, TF/DD, and then document their decisions in harmony with regulations.

• Senior management
• Regulatory affairs
• Quality Assurance
• Production
• Engineering & R&D